TRIA FIRM URETERAL STENT SETS

Report

• Report Number: 2124215-2026-27332
• Event Type: Injury
• Date Received: May 20, 2026
• Report Date: May 20, 2026
• Manufacturer: BOSTON SCIENTIFIC CORPORATION
• Product Code: FAD
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

TIMEFRAME OF EVENT DATA: EVENTS FROM URETERAL STENT INSERTION AND REMOVAL PERFORMED WITHIN THE YEAR OF 2020-2025. SUMMARY OF EVENTS: FOLLOWING PROCEDURES IN INVOLVING TRIA SOFT URETERAL STENTS, A TOTAL OF 55 PATIENTS EXPERIENCED INFECTION, 55 PATIENTS EXPERIENCED PAIN, AND 1, 762 PATIENTS HAD INCIDENTS FOR STENT SYMPTOMS. DEVICE EVALUATION: UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, ANONYMIZED DATA WAS PROVIDED. NO PRODUCTS WERE RETURNED AS PART OF THE REGISTRY. IT CANNOT BE DETERMINED IF THESE EVENTS HAVE BEEN PREVIOUSLY REPORTED OR IF THE DEVICES WERE RETURNED FOR ANALYSIS AS PART OF A PREVIOUSLY REPORTED SPONTANEOUS COMPLAINT. AS THE DEVICE IS NOT AVAILABLE FOR ANALYSIS, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. CONTEXTUAL ANALYSIS OF STUDY DATA: INFECTION: INFECTION RATES FOR URETERAL STENTS IDENTIFIED IN THE CLINICAL LITERATURE INCLUDE 8.1-20.0% FOR FEVER, UP TO 20.5% FOR GENERAL/UNSPECIFIED INFECTION, AND 0-21% FOR URINARY TRACT INFECTIONS. THE INFECTION RATES IDENTIFIED IN THIS ACTIVITY FOR TRIA FIRM (1.9%) AND TRIA SOFT (2.0%) ARE WITHIN THIS RATE RANGE FOR URETERAL STENTS. PAIN: PAIN RATES FOR URETERAL STENTS IDENTIFIED IN THE CLINICAL LITERATURE ARE REPORTED AS PAIN/ANALGESIA USE/DISCOMFORT RATES AND HAVE A REPORTED RATE RANGE OF 16.4-70%. THE PAIN RATES IDENTIFIED IN THIS ACTIVITY FOR TRIA FIRM (1.0%) AND TRIA SOFT (1.3%) ARE BELOW THIS RATE RANGE FOR URETERAL STENTS AND AS SUCH ARE CONSIDERED INLINE AND ACCEPTABLE. STENT SYMPTOMS: STENT SYMPTOM RATES IDENTIFIED IN THE CLINICAL LITERATURE ARE REPORTED TO HAVE A RATE RANGE OF 57.9%-59.5%. THE STENT SYMPTOM RATES IDENTIFIED IN THIS ACTIVITY FOR TRIA FIRM (41.8%) AND TRIA SOFT (45.0%) ARE BELOW THIS RATE RANGE FOR URETERAL STENTS AND AS SUCH ARE CONSIDERED INLINE AND ACCEPTABLE. THERE WERE NO UNEXPECTED ADVERSE EVENTS IN THIS STUDY. 2. GAUHAR V, PIROLA GM, SCARCELLA S, ET AL. NEPHROSTOMY TUBE VERSUS DOUBLE J URETERAL STENT IN PATIENTS WITH MALIGNANT URETERIC OBSTRUCTION. A SYSTEMATIC REVIEW AND META-ANALYSIS OF COMPARATIVE STUDIES. INT BRAZ J UROL. NOV-DEC 2022;48(6):903-914. 3. WANG X, WU G, WANG T, ET AL. META-ANALYSIS OF PERIOPERATIVE OUTCOMES AND SAFETY OF PERCUTANEOUS NEPHROSTOMY VERSUS RETROGRADE URETERAL STENTING IN THE TREATMENT OF ACUTE OBSTRUCTIVE UPPER URINARY TRACT INFECTION. THER ADV UROL. JAN-DEC 2024;16:17562872241241854. DOI:10.1177/17562872241241854 4. HARRISON NL, HUGHES C, SOMANI BK. IS STENT ON A STRING THE NEW GOLD STANDARD FOR POSTURETEROSCOPY URETERAL DRAINAGE? EVIDENCE FROM A SYSTEMATIC REVIEW. J ENDOUROL. FEB 2024;38(2):159-169. 5. GORDON P, THOMPSON D, PATEL O, MA R, BOLTON D, ISCHIA J. URETERIC STENTING OUTSIDE OF THE OPERATION THEATRE: CHALLENGES AND OPPORTUNITIES. BJU INT. OCT 8 2024; 6. AHMAD MU, SIDDIQUI S, ASHRAF FA, ET AL. RETROGRADE URETERAL STENTS VERSUS PERCUTANEOUS NEPHROSTOMY IN THE MANAGEMENT OF MALIGNANT URETERAL OBSTRUCTION: A SYSTEMATIC REVIEW AND META-ANALYSIS. UROLOGY. OCT 2024;192:158-167. DOI:10.1016/J.UROLOGY.2024.05.042 7. FIUK J, BAO Y, CALLEARY JOHN G, SCHWARTZ BRADLEY F, DENSTEDT JOHN D. THE USE OF INTERNAL STENTS IN CHRONIC URETERAL OBSTRUCTION. JOURNAL OF UROLOGY. 2015/04/01 2015;193(4):1092-1100. DOI:10.1016/J.JURO.2014.10.123 8. PUTRANTYO II, WARLI SM, SIREGAR GP, PRAPISKA FF, KADAR DD, SIHOMBING B. ROLE OF URETERAL STENT MATERIAL AND COATING TO PREVENT URETERAL STENT RELATED ISSUE: A SYSTEMATIC REVIEW AND META ANALYSIS. ARCH ITAL UROL ANDROL. MAR 4 2024;96(1):12067. 9. SHAH M, BLEST F, BLACKMUR J, LAIRD A, DAWSON S, ANING J. MALIGNANT UPPER URINARY TRACT OBSTRUCTION IN CANCER PATIENTS: A SYSTEMATIC REVIEW. BJUI COMPASS. MAY 2024;5(5):405-416. 10. ZUL KHAIRUL AZWADI I, NORHAYATI MN, ABDULLAH MS. PERCUTANEOUS NEPHROSTOMY VERSUS RETROGRADE URETERAL STENTING FOR ACUTE UPPER OBSTRUCTIVE UROPATHY: A SYSTEMATIC REVIEW AND META-ANALYSIS. SCI REP. MAR 23 2021;11(1):6613. DOI:10.1038/S41598-021-86136-Y 11. CHEN Y, FENG J, YUE Y, ET AL. EXTERNALIZED URETERAL CATHETER VERSUS DOUBLE-J STENT IN TUBELESS PERCUTANEOUS NEPHROLITHOTOMY FOR UPPER URINARY STONES: A SYSTEMATIC REVIEW AND META-ANALYSIS. J ENDOUROL. JUL 2018;32(7):581-588. 12. TANIA C, TOBING E, TANSOL C. COMPARISON OF EXTERNAL URETERAL CATHETER AND DOUBLE-J STENT AS DRAINAGE METHODS FOR TUBELESS PERCUTANEOUS NEPHROLITHOTOMY: A SYSTEMATIC REVIEW AND META-ANALYSIS. INT BRAZ J UROL. JAN-FEB 2025;51(1) RACE: ASIAN 2.0%, BLACK 9.4%, OTHER RACE 6.4%, UNKNOWN 6.3%, AND WHITE 76%. ETHNICITY: NOT HISPANIC OR LATINO 86%, HISPANIC OR LATINO 9.3%, AND UNKNOWN 4.2%. AGE: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%) PRODUCT (DEVICE) DETAILS: THE UPN IS UTILIZED TO CAPTURE TRIA SOFT EVENTS. IN THE ABSENCE OF AN AVAILABLE UNKNOWN UPN SPECIFIC TO TRIA SOFT, THE TRIA FIRM UPN HAS BEEN APPLIED FOR REPORTING PURPOSES.

Description of Event or Problem · 0

bdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1301; E1304; E1302; E1605; E1308.,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E1906,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;22901752,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral",UNK-P-Tria_Ureteral_Stent,,,,,K924608,2/19/2026,IN,"This report summarizes 55 incidents for infection, 55 incidents for pain, and 1,762 incidents for stent symptoms. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft stents, 54 patients experienced infection, 45 patients experienced pain, and 1, 827 patients had incidents for stent symptoms consisting of urinary frequency, dysuria, micturition urgency, hematuria, and, muscle spasm.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data include newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 55 patients experienced infection, 55 patients experienced pain, and 1, 762 patients had incidents for stent symptoms.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Infection:; Infection rates for ureteral stents identified in the clinical literature include 8.1-20.0% for fever, up to 20.5% for general/unspecified infection, and 0-21% for urinary tract infections. The infection rates identified in this activity for Tria Firm (1.9%) and Tria Soft (2.0%) are within this rate range for Ureteral Stents.;;Pain:;Pain rates for ureteral stents identified in the clinical literature are reported as Pain/Analgesia use/Discomfort rates and have a reported rate range of 16.4-70%. The pain rates identified in this activity for Tria Firm (1.0%) and Tria Soft (1.3%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;Stent symptoms:;Stent symptom rates identified in the clinical literature are reported to have a rate range of 57.9%-59.5%. The stent symptom rates identified in this activity for Tria Firm (41.8%) and Tria Soft (45.0%) are below this rate range for Ureteral Stents and as such are considered inline and acceptable.;;There were no unexpected adverse events in this study.;;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;8. Putrantyo II, Warli SM, Siregar GP, Prapiska FF, Kadar DD, Sihombing B. Role of ureteral stent material and coating to prevent ureteral stent related issue: A systematic review and meta analysis. Arch Ital Urol Androl. Mar 4 2024;96(1):12067. ;9. Shah M, Blest F, Blackmur J, Laird A, Dawson S, Aning J. Malignant upper urinary tract obstruction in cancer patients: A systematic review. BJUI Compass. May 2024;5(5):405-416. ;10. Zul Khairul Azwadi I, Norhayati MN, Abdullah MS. Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis. Sci Rep. Mar 23 2021;11(1):6613. doi:10.1038/s41598-021-86136-y;11. Chen Y, Feng J, Yue Y, et al. Externalized Ureteral Catheter Versus Double-J Stent in Tubeless Percutaneous Nephrolithotomy for Upper Urinary Stones: A Systematic Review and Meta-Analysis. J Endourol. Jul 2018;32(7):581-588. ;12. Tania C, Tobing E, Tansol C. Comparison of External Ureteral Catheter and Double-J stent as Drainage Methods for Tubeless Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Int Braz J Urol. Jan-Feb 2025;51(1);;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available unknown UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2330,F24,A24,G07001,B17,C19,D12,No,0;

Description of Event or Problem · 0

THIS REPORT SUMMARIZES 55 INCIDENTS FOR INFECTION, 55 INCIDENTS FOR PAIN, AND 1,762 INCIDENTS FOR STENT SYMPTOMS. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. TYPE OF PROCEDURE: PATIENT OUTCOMES FOR TRIA SOFT URETERAL STENTS APPROVED FOR LONG INDWELL TIMES IN PATIENTS WITH KNOWN STENT INSERTION AND REMOVAL DATES BOSTON SCIENTIFIC PERFORMED A RETROSPECTIVE REVIEW OF THE BOSTON SCIENTIFIC TRIA SOFT URETERAL STENTS IN THE TRUVETA DATABASE. THIS ANALYSIS AIMED TO ASSESS PATIENT OUTCOMES WITH URETERAL STENTS APPROVED FOR LONG INDWELL TIMES. THE PROCEDURES WERE PERFORMED FROM THE YEARS 2020-2025. WITHIN THIS ANALYSIS, A TOTAL OF 8,582 PATIENTS UNDERWENT TRIA URETERAL STENT INSERTION AND REMOVAL. FOLLOWING PROCEDURES INVOLVING TRIA SOFT STENTS, 55 PATIENTS EXPERIENCED INFECTION, 55 PATIENTS EXPERIENCED PAIN, AND 1,762 PATIENTS HAD INCIDENTS FOR STENT SYMPTOMS CONSISTING OF URINARY FREQUENCY, DYSURIA, MICTURITION URGENCY, HEMATURIA, AND, MUSCLE SPASM. PATIENT EVENTS WERE IDENTIFIED AS EVENT TERMS WITH RATES. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT. DATA INCLUDE NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. DATA OBTAINED FROM TRUVETA FOR THIS STUDY IS DE-IDENTIFIED BEFORE BEING ACCESSED BY BOSTON SCIENTIFIC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO OUR ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED AS A SPONTANEOUS COMPLAINT. THE STUDY DATA DOES NOT PROVIDE A CAUSALITY RELATIONSHIP FOR EACH REPORTED EVENT TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE TO BSC.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
393146	TRIA FIRM URETERAL STENT SETS	STENT, URETERAL	FAD	BOSTON SCIENTIFIC CORPORATION	UNK-P-TRIA_URETERAL_STENT

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 7

• Cramp(s) /Muscle Spasm(s)
• Dysuria
• Hematuria
• Micturition Urgency
• Pain
• Unspecified Infection
• Urinary Frequency / Polyuria

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Source type · 1

• Other

Type of report · 1

• Initial submission